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FDA 510(k)

安全注射针

K号: K222801 · 2023-01-25

决定日期2023-01-25
产品代码FMK
咨询委员会SU 请注意,您提供的文本“SU”不足以进行翻译。请提供完整的描述性文本以便进行翻译。
决定实质等同

器械摘要

Safety Lancet is the device name listed in this FDA 510(k) record. The listed applicant is Sarstedt AG & CO KG. It received FDA 510(k) clearance on 2023-01-25 under 510(k) number K222801. The device is classified under product code FMK. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Safety Lancet?

Safety Lancet is a medical device that received FDA 510(k) clearance on 2023-01-25. The listed applicant is Sarstedt AG & CO KG. The 510(k) number is K222801.

When did Safety Lancet receive FDA 510(k) clearance?

Safety Lancet received FDA 510(k) clearance on 2023-01-25, under 510(k) number K222801.

Who is the listed applicant for Safety Lancet?

The FDA 510(k) record lists Sarstedt AG & CO KG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Safety Lancet?

The FDA product code for Safety Lancet is FMK.

相关临床试验

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系;请查阅链接的官方来源。

相关器械(代码:FMK)

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系;请查阅链接的官方来源。

官方来源

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